QUALITROL 2H Insert. 01 Inglês - Ref.: 72. Ref.:72. Precautions and warnings

Transcription

1 QUALITROL 2H Insert Ref.:72 Lot 6002 Expiration 2019/08/23 Precautions and warnings Qualitrol 2H is for in vitro diagnostic use only. Attention. It is suggested to verify carefully if the lot number pressed in this instruction corresponds to the lot on the Qualitrol 1 H bottle label. Intended use. Qualitrol 2H is a preparation lyophilized, in human protein matrix, containing several analytes for quality control of clinical chemistry assays. Product description. Qualitrol 2H is a preparation lyophilized in human protein matrix, containing several analytes whose values were adjusted by adding animal tissue extracts and other non-protein constituents such as purified chemical materials. Product characteristics. Qualitrol 2H is appropriated for quality control of clinical chemistry assays, and may be applied for measuring analytical imprecision and the verification of the calibration deviation of the quantitative process commonly used in clinical laboratory. Its utilization represents a benefit, since it allows the use of only one material of control to a significant number of analytes in the intern control quality. The simultaneous use of Qualitrol 1H and Qualitrol 2H allows verifying the precision of several analytes in different levels of concentration making possible the application of Westgard rules that are powerful tools for obtaining winnings on quality and productivity, minimizing the unnecessary repetitions caused by false rejection signs that occur very often when it is used a control in only one concentration level. Qualitrol 2H may be also used successfully on the automated and manual assays. Reagents 1. CONTROL 2 - Qualitrol 2H - Store at 2-8ºC. Lyophilized preparation containing several analytes in human protein matrix. Reagent label bears expiration date. Chemical or microbial contamination may occur during handling the product and decrease the stability. For the analytes concentrations see Assigned Values. Qualitrol 2H is prepared from human blood derivatives and was tested for the presence of HBsAg and antibodies anti-hcv and anti-hiv presenting negative results. Despite the use of validated and approved tests, none of them may assure that the derivatives products of human blood are free of infectious agents. Therefore, the usual security cares should be applied on the reagent handling. Disposal of all waste material should be in accordance with local guidelines. Reagent water quality. The deionized or distilled water in the laboratory to prepare reagents, use in the measurements and for final glass washing must have resistivity 1 megaohm.cm, or conductivity 1 microsiems/cm and silicates concentration must be < 0.1mg/L. Preparation Hit carefully the tube with the finger in order to loosen the lyophilized material from the tube. Remove the plastic and rubber lids. Using a calibrated volumetric pipette, add to the bottle exactly 5.0 ml of deionized or distilled water, at 22-28ºC. Close the bottle with the rubber lid,hit carefully the bottle with the finger, and let it rest for 10 minutes, homogenize gently by rotation for mixing. Invert the bottle gently until the complete dissolution of the material. Before use, homogenize gently, open the bottle and get the necessary amount for using. Close immediately and keep protected from light at 2-8ºC. Storage and stability. Unopened reagents, when stored at indicated temperature, are stable up to expiration date shown on the label. After the dissolution, the analytes of Qualitrol 2H, except for bilirubin and alkaline phosphatase, are stable 7 days at 2-8ºC in a tightly closed bottle and protected from light. Bilirubin and alkaline phosphatase are stable 2 days at 2-8ºC in a tightly closed bottle. Some analytes of Qualitrol 2H (bilirubin and creatine kinase) are sensitive to light therefore the light exposure should be avoided. All the analytes, except for bilirubin and alkaline phosphatase, are stable 15 days at -20ºC, when stored in a hermetically closed bottle and protected from light. 01 Inglês - Ref.: 72

2 In order to avoid repetitive freezing and melting, it is suggested to aliquot the control material in 0.5 ml to 1.0 ml before freezing. In order to avoid evaporation of the material, it is suggested to use appropriated tubes for freezing (cryotubes). The temperature of the freezer of a common refrigerator is around - 8ºC. General instructions. Qualitrol 2H dissolved is ready for using and must be processed exactly as proposed for patient samples. When stored in the refrigerator and mainly frozen, the material of control must be homogenized before using. Do not use vortex and mix gently. Be as fast as possible in order to not keep it out of the storage temperature or light exposed, and keep the control material bottle closed most of time. Limitations. Several factors alter the results obtained with Qualitrol 2H. Among these factors are the dissolution, homogenization, water or glasses contaminants, and inappropriate control of temperature or technical errors associated to equipment or the reagent systems. It is suggested to follow the Good Practices in Clinical Laboratories and the verification of the equipment and reagents instructions, related to the procedures limitations. Expected values. Expected values and intervals of concentrations of several constituents of Qualitrol 2H were obtained after statistical analysis of the results measured by manual and automated systems using Labtest reagents. These values should be used as initial reference only. The laboratory must determine the averages and interval of concentration of all constituents of Qualitrol 2H using their own assays procedures, since difference can be found due the reagents diversities, calibration systems, equipments and imprecision of measurement procedures. The average and interval of concentrations found by the laboratory may be used for intern quality control of the assays. As maximum threshold of control, it is recommended to use the average value ± 2 or 3 times the standard deviation obtained by the laboratory. Alternatively, the desired specifications for imprecision derivative for biological variation (BV) may be used. BV can be found at the site: Assigned values. The concentration values are determined after statistical analysis and only refer to the specific lot of Qualitrol 2H. The enzymatic measurements were performed at 37ºC. Due to Qualitrol 2H human origin, it contains another analytes beyond those described in the following table. Therefore, for the analytes that are not described in the table, the Qualitrol 2H may be used as a control of unknown value. References 1. Westgard JO, Grothy T. A multi-rule Shewhart chart for quality control in Clinical Chemistry. Clin Chem 1981; 27: Broome E, Cembrowski, GS, Kahn SN, Martin PL, Patrick CA. Implemention and use of a manual multi-rule quality control procedure. Laboratory Medicine 1985; 16: Cembrowski, G. Thoughts on quality-control systems: a laboratorian's perspective. Clin Chem 1997; 43: Presentation Product Reference Contents Qualitrol 2H Customer information [Warranty conditions] CONTROL 2 CONTROL 2 1 X 5 ml 6 X 5 ml Labtest Diagnóstica warrants the performance of this product under the specifications until the expiration date shown in the label since the application procedures and storage conditions, indicated on the label and in this insert, have been followed correctly. Labtest Diagnóstica S.A. CNPJ: / Av. Paulo Ferreira da Costa, Vista Alegre - CEP Lagoa Santa. Minas Gerais Brasil - Customer Service customerservice@labtest.com.br Revision: July, 2014 Ref.: Copyright by Labtest Diagnóstica S.A. Reproduction under previous autorization 02 Inglês - Ref.: 72

3 Attention. Make sure that the lot number labeled on the bottle of Qualitrol 2H corresponds to the same lot on this insert. Qualitrol 2H - Systems with monochromatic readings Lot: 6002 Expiration: 2019/08/23 Conventional s s IS Ref Analytes Method 140* Uric Acid Enzymatic mg/dl µmol/l 19 Albumin VBC g/dl µmol/l 108 ALT/GPT with Pyridoxal Phosphate IFCC UV U/L nkat/l ALT/GPT without Pyridoxal Phosphate IFCC UV U/L nkat/l 142 Amylase CNPG U/L µkat/l 11 Caraway U/dL 109 AST/GOT with Pyridoxal Phosphate IFCC UV U/L nkat/l AST/GOT without Pyridoxal Phosphate IFCC UV U/L nkat/l 31 Direct Bilirubin Sims-Horn mg/dl µmol/l Total bilirubin Sims-Horn mg/dl µmol/l 93 Direct bilirubin DCA mg/dl µmol/l 94 Total bilirubin DCA mg/dl µmol/l 95 Calcium Arsenaze III mg/dl mmol/l 90 Cresolftalein mg/dl mmol/l 41 Iron Binding Capacity Goodwin modified µg/dl µmol/l 92 Ferrozine µg/dl µmol/l 115 Chloride Thiocyanate meq/l mmol/l 76 Cholesterol Enzymatic mg/dl mmol/l 98 Selective Surfactant mg/dl mmol/l 128 HDL Cholesterol Selective Surfactant mg/dl mmol/l 145 Selective Surfactant mg/dl mmol/l 111 LDL Cholesterol Selective Surfactant mg/dl mmol/l 129 Selective Surfactant mg/dl mmol/l 139 Cholinesterase Kinetic - DGKC U/L nkat/l 117 Creatine Kinase IFCC U/L µkat/l 35 End point mg/dl µmol/l 96 Creatinine kinetic mg/dl µmol/l 127 Enzymatic mg/dl µmol/l 86 Lactic Dehydrogenase Kinetic UV U/L µkat/l 38 Iron Ferrozine µg/dl µmol/l 91 Ferrozine µg/dl µmol/l 40 Alkaline Phosphatase Thymolphthalein U/L µkat/l 79 PNPP U/L µkat/l 03 Inglês - Ref.: 72

4 Qualitrol 2H - Systems with monochromatic readings Lot: 6002 Expiration: 2019/08/23 Conventional s s IS Ref Analytes Method 12 Phosphorus UV mg/dl mmol/l 42 Colorimetric mg/dl mmol/l 105 Gamma GT Continuous kinetic U/L nkat/l 133 GOD-Trinder mg/dl mmol/l Glucose GOD-Trinder*** mg/dl mmol/l 134 GOD-Trinder mg/dl mmol/l 137* Enzymatic HK mg/dl mmol/l 138 Lactate Enzymatic mg/dl mmol/l 107 Lipase Colorimetric enzymatic U/L µkat/l 50 Magnesium Magon/Xilidil blue mg/dl mmol/l 20 Mucoproteins Winsler modified mg/dl 99 Total Proteins Biuret g/dl g/l 52 Oxaloacetic Transaminase R. Frankel U/mL 53 Pyruvic Transaminase R. Frankel U/mL 87 Triglycerides Enzymatic mg/dl mmol/l 27 Urea Enzymatic colorimetric mg/dl mmol/l 104 Enzymatic UV mg/dl mmol/l *Procedure without blank of sample. ***Value attributed to Labmax Plenno without sample blank. 1. The target value and the range of the HDL Cholesterol and LDL Cholesterol can change due to the application procedure and the automated equipment. 04 Inglês - Ref.: 72

5 Qualitrol 2H - Systems with bichromatic readings Lot: 6002 Expiration: 2019/08/23 Conventional s s IS Ref Analytes Method 140 Uric Acid Enzymatic mg/dl µmol/l 19 Albumin VBC g/dl µmol/l ALT/GPT with Pyridoxal Phosphate IFCC UV U/L nkat/l 108 ALT/GPT without Pyridoxal Phosphate IFCC UV U/L nkat/l 142 Amylase CNPG U/L µkat/l AST/GOT with Pyridoxal Phosphate IFCC UV U/L nkat/l 109 AST/GOT without Pyridoxal Phosphate IFCC UV U/L nkat/l Direct Bilirubin Sims-Horn mg/dl µmol/l 31 Total Bilirubin Sims-Horn mg/dl µmol/l 93 Direct Bilirubin DCA mg/dl µmol/l 94 Total Bilirubin DCA mg/dl µmol/l 95 Arsenaze III mg/dl mmol/l Calcium 90 Cresolftalein mg/dl mmol/l 92 Iron Binding Capacity Ferrozine µg/dl µmol/l -- Ion-selective electrodes meq/l mmol/l Chloride 115 Thiocyanate meq/l mmol/l 76 Cholesterol Enzymatic mg/dl mmol/l 98 Selective Surfactant mg/dl mmol/l 128 HDL Cholesterol Selective Surfactant mg/dl mmol/l 145 Selective Surfactant mg/dl mmol/l 111 Selective Surfactant mg/dl mmol/l LDL Cholesterol 129 Selective Surfactant mg/dl mmol/l 139 Cholinesterase Kinetic - DGKC U/L nkat/l 117 Creatine kinase IFCC U/L µkat/l 96 kinetic mg/dl µmol/l Creatinine 127 Enzymatic mg/dl µmol/l 86 Lactic Dehydrogenase Kinetic UV U/L µkat/l 91 Iron Ferrozine µg/ml µmol/l 79 Alkaline phosphatase PNPP U/L µkat/l 12 Phosphorus UV mg/dl mmol/l 105 Gamma GT Continuous kinetic U/L nkat/l 133 GOD-Trinder mg/dl mmol/l 134 Glucose GOD-Trinder mg/dl mmol/l 137 Enzymatic HK mg/dl mmol/l 138 Lactate Enzymatic mg/dl mmol/l 107 Lipase Colorimetric enzymatic U/L µkat/l 50 Magnesium Magon/Xilidil blue mg/dl mmol/l 05 Inglês - Ref.: 72

6 Qualitrol 2H - Systems with bichromatic readings Lot: 6002 Expiration: 2019/08/23 Conventional s s IS Ref Analytes Method -- Ion-selective electrodes meq/l mmol/l Potassium 125 Enzymatic meq/l mmol/l 99 Total Proteins Biuret g/dl g/l -- Ion-selective electrodes meq/l mmol/l Sodium 124 Enzymatic meq/l mmol/l 87 Triglycerides Enzymatic mg/dl mmol/l 104 Urea Enzymatic UV mg/dl mmol/l 1. The target value and the range of the HDL Cholesterol and LDL Cholesterol can change due to the application procedure and the automated equipment. 06 Inglês - Ref.: 72